An innovator of medical devices is searching for a IT Quality Systems Engineer to help support their IT and quality teams and ensure their Quality Systems are maintained effectively and conform to regulatory standards. This permanent position is a fantastic opportunity to join a large company that is in an exciting period of growth and expansion.
This role is an opportunity for a skilled IT Engineer with a background in quality systems and GxP regulations and a pragmatic approach to quality, to work for one of the most progressive and developed companies in its field. With a strong established background in IT, you will have deep knowledge of IT compliance and validation from a pharmaceutical background. This role is a business as usual role, supporting the day to Quality Systems IT and ensuring regulatory standards are upheld.
With a strong experience of working with multiple teams, your core responsibilities will be the following;
- Working with IT supporting all IT Quality Systems management activities.
- Supporting validation and qualification requirements.
- Ensuring regulatory standards are adhered to with the Quality Systems (VPP’s, OQ & PQ, CCR’s, VSR’s)
- Supporting IT teams with Quality System tasks and regularly auditing IT validation systems, performing corrective and preventative actions to fix any issues and ensure systems retain their validated status.
- Updating qualification documentation and reviewing, analyzing and reporting the results to the system owners.
- Creating and maintaining IT quality standard operating procedures and policy documents.
- Supporting CSV projects to ensure that qualification activities are assessed, documented and delivery accurately and effectively.
- Collaborating with all system owners, stakeholders and teams to ensure all systems continue conform to MHRA & FDA regulations for data integrity.
- Maintaining the GMP System Inventory.
- Other ad hoc business as usual takes as and when required for the role.
With years of experience working with IT Engineering and quality systems or in a GxP environment, this company is looking for a pragmatic IT Quality Systems Engineer with strong commercial awareness and a strong IT background. The company is looking for a strong team player, who is looking to collaborate rather than dictate and cooperate with the various teams, system owners and stakeholders to find the best solution. The reward for this is a strong scope for progression, great autonomy in the role and the chance to develop and grow within a highly progressive company.
With a competitive salary of up to £45,000 depending on experience, this company offer a range of benefits including a 10% annual bonus, up to 5% company contribution to pension, life assurance four times the salary, private health and dental care and a share save scheme. This company is at the forefront of it’s field and this represents a great opportunity to be part of one of the most exciting medical devices companies in the country.
This is a Permanent Vacancy.